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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
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US Department of Justice
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Generated: February 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203536

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NDA 203536 describes VALSARTAN, which is a drug marketed by Alembic Pharms Ltd, Amneal Pharms, Aurobindo Pharma Ltd, Hetero Labs Ltd V, Ivax Pharms, Jubilant Generics, Lupin Ltd, Macleods Pharms Ltd, Mylan Pharms Inc, Ohm Labs Inc, Prinston Inc, Torrent Pharms Ltd, Watson Labs Inc, Apotex Inc, and Watson Labs Teva, and is included in twenty-one NDAs. It is available from thirty suppliers. Additional details are available on the VALSARTAN profile page.

The generic ingredient in VALSARTAN is hydrochlorothiazide; valsartan. There are thirty-one drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; valsartan profile page.
Summary for 203536
Tradename:VALSARTAN
Applicant:Jubilant Generics
Ingredient:valsartan
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 203536
Medical Subject Heading (MeSH) Categories for 203536
Suppliers and Packaging for NDA: 203536
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VALSARTAN valsartan TABLET;ORAL 203536 ANDA Jubilant Cadista Pharmaceuticals Inc. 59746-360 N 59746-360-03
VALSARTAN valsartan TABLET;ORAL 203536 ANDA Jubilant Cadista Pharmaceuticals Inc. 59746-360 N 59746-360-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength40MG
Approval Date:Jan 5, 2015TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength80MG
Approval Date:Jan 5, 2015TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength160MG
Approval Date:Jan 5, 2015TE:ABRLD:No

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